DURECT Announces Update on Remoxy®

                      DURECT Announces Update on Remoxy®

PR Newswire

CUPERTINO, Calif., May 10, 2013

CUPERTINO, Calif., May 10, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq:
DRRX) today announced that Pfizer has provided an update on Remoxy as part of
their Form 10-Q filing. Pfizer's disclosure is as follows: "In 2005, King
Pharmaceuticals, Inc. (King) entered into an agreement with Pain Therapeutics,
Inc. (PT) to develop and commercialize Remoxy. In August 2008, the FDA
accepted the NDA for Remoxy that had been submitted by King and PT. In
December 2008, the FDA issued a "complete response" letter. In March 2009,
King exercised its right under the agreement with PT to assume sole control
and responsibility for the development of Remoxy. In December 2010, King
resubmitted the NDA for Remoxy with the FDA. In June 2011, we and PT
announced that a "complete response" letter was received from the FDA with
regard to the resubmission of the NDA. We have been working to address the
issues raised in the letter, which primarily relate to manufacturing. We met
with the FDA in March 2013 to discuss our plan to address the June 2011
"complete response" letter. We received written guidance from the FDA in May
regarding required next steps, including additional clinical studies, to
address the letter. Based on this guidance, we are considering our options
with respect to Remoxy. If we elect to continue development of Remoxy,  we 
would not expect to submit a response to the "complete response" letter before
mid-2015."

(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)

We understand from Pfizer that additional clinical studies are necessary and
include, in part, a pivotal bioequivalence study with the modified
formulationto bridge to the clinical data conducted with the original
formulation, as well as an abuse potential study with the modified Remoxy
formulation.

About Remoxy

Remoxy,  an investigational drug, is a unique long  acting oral formulation of
oxycodone intended to treat moderate-to-severe pain when a continuous, around
the clock opioid analgesic is needed for an extended period of time. Based on
DURECT's ORADUR technology, which is covered by issued patents and pending
patent applications owned by us, Remoxy is designed to discourage common
methods of tampering associated with prescription opioid analgesic misuse and
abuse.

About DURECT Corporation

DURECT is a specialty pharmaceutical company developing innovative drugs for
pain and other chronic diseases, with late-stage development programs
including Remoxy^®, POSIDUR^™, ELADUR^®, and TRANSDUR^®-Sufentanil. DURECT's
proprietaryoral, transdermal and injectable depot delivery technologies
enable new indications and superior clinical/commercial attributes such as
abuse deterrence, improved convenience, compliance, efficacy and safety for
small molecule and biologic drugs. For more information, please visit
www.durect.com.

DURECT Forward-Looking Statement

The statements in this press release regarding Remoxy, the potential continued
development of Remoxy by Pfizer, additional trials and studies, the potential
resubmission of the NDA to the FDA, the potential regulatory approval of
Remoxy by the FDA, and the potential benefits and uses of Remoxy are
forward-looking statements involving risks and uncertainties that can cause
actual results to differ materially from those in such forward-looking
statements. Potential risks and uncertainties include, but are not limited to,
the risk that additional trials and studies will not have satisfactory
outcomes, the risk that Pfizer will discontinue development of Remoxy, the
risk that Pfizer may want to renegotiate terms in the agreements associated
with Remoxy, the risk of adverse decisions by regulatory agencies, including
product non-approval, delays and additional costs due to requirements imposed
by regulatory agencies, potential adverse effects arising from the testing or
use of Remoxy, the potential that the data submitted by Pfizer in response to
the complete response letter will not be deemed sufficient by FDA or other
regulatory agencies to support regulatory approval of Remoxy, and the risk of
obtaining marketplace acceptance of Remoxy, avoiding infringing patents held
by other parties and securing and defending patents of our own, and managing
and obtaining capital to fund our growth, operations and expenses. Further
information regarding these and other risks is included in DURECT's Form 10-Q
on May 3, 2013 under the heading "Risk Factors."

NOTE: POSIDUR^™, SABER^®, TRANSDUR^®, and ELADUR^™ are trademarks of DURECT
Corporation. Remoxy, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug
candidates under development and have not been approved for commercialization
by the U.S. Food and Drug Administration or other health authorities.

SOURCE DURECT Corporation

Website: http://www.durect.com
Contact: Matthew J. Hogan, Chief Financial Officer, DURECT, 408-777-4936
 
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